Syringe device, system and method for delivering ozone gas

ABSTRACT

In accordance with at least one exemplary embodiment, a syringe device, method and system for delivering a therapeutic amount of ozone are disclosed. A sterility case can enclose a syringe portion and can maintain sterility while the syringe device is interfaced to an ozone generator. A valvably-controlled fluid channel can extend from the barrel of the syringe through the case. Conducting elements can be attached to the case and can breach the case. The conductive elements can be connected to electrodes. The electrodes can be attached to the syringe. The syringe portion can be filled with oxygen gas via the valvably-controlled fluid channel. An electric current can be provided to the conductive elements from an ozone generator resulting in a corona discharge from at least one electrode. A therapeutic amount of ozone gas can be produced from the oxygen gas and the syringe delivered into the sterile field without compromise.

BACKGROUND

Ozone is an unstable gas with a half-life of less than one hour at roomtemperature. Ozone is a powerful oxidizer. It is a known bactericide andviricide. Methods for converting oxygen to ozone involve high-voltagecorona discharge or ultraviolet light. Ozone generators making use ofsuch methods are available for industrial uses.

Ozone has a variety of industrial applications. Applications includedeodorizing air, purifying water and sterilizing medical instruments,among others. Ozone and conventional medical ozone generators are beingused therapeutically in many countries and have been so for severalyears. Such applications include, but are not limited to,autohemotherapy, rectal insufflations, intradiscal injection, injectioninto knee and shoulder joints, and full body exposure.

For example, ozone is used to treat diffuse bulging or containedherniation of the spinal disc. Spinal discs are composed of a fibrousouter ring made of Type I collagen and a softer more flexible nucleusmade of Type II collagen, proteoglycans and water. Patients with discbulging or herniation suffer from pain caused by disc compression of theneurological elements, including the spinal cord, cauda equina and nerveroots. Intradiscal ozone treatment involves direct injection of agaseous mixture of oxygen and ozone into the nucleus of the disc. Ozonereleases water from the proteoglycans, reducing disc size and relievingcompression of neurological elements. Some investigators believe thatozone stimulates anti-inflammatory mediators and initiates a healingresponse.

The mechanism of action and reported success rates of ozone treatmentfor spinal disc herniation are comparable to that of the enzymechymopapain. Chymopapain was first FDA-approved in 1983 and was widelyused with a success rate of 65-85%. A small number of seriouscomplications, including death and paralysis, caused the product to losefavor in the U.S. market.

Ozone and chymopapain are two means of performing a chemical discectomythrough a needle puncture. This minimally invasive approach may bepreferred to surgical discectomy, which requires general anesthesia anddirect access to the spinal disc.

Therapeutic ozone must be delivered shortly after being produced fromoxygen. Conventional medical ozone generators pass medical grade oxygenthrough an electric field or ultraviolet light. This process converts anamount of oxygen into ozone. Typically, a syringe is interfaced with thegenerator and ozone is withdrawn from a gas chamber of the generatorinto the syringe for subsequent injection therapy. Often, a spinalneedle is already positioned within a patient and then the syringe isplaced in fluid communication with the needle for injection.

The preferred concentration of ozone for intradiscal injection isapproximately 6%. The concentration of ozone is important for medicaluses. If the concentration is too low, the treatment will not beeffective. If the concentration of ozone is too high, detrimentaleffects may follow.

As such, medical ozone generators include a means for measuring theconcentration of ozone. Conventional ozone generators also have meansfor controlling the concentration and delivery of ozone gas. Forexample, some generators include components that neutralize excessozone. Other generators continuously vent ozone.

Conventional ozone generators typically include permanent and reusableelectrodes. The gas chambers of conventional generators are oftenpermanent and reusable as well. Reusable electrodes tend to degrade overtime. Sterility is an issue for present ozone generators that passoxygen through permanent and reusable gas chambers. The bioburden ofthese machines is unknown. Thus, the ability of ozone to sterilize thesecomponents cannot be validated. To address such, medical professionalshave been known to inject the gas through a bacterial filter butcompliance with this practice is sporadic as filters may not beavailable or the clinician may be trying to minimize equipment cost.

SUMMARY

According to at least one exemplary embodiment, a syringe device forproducing an amount of ozone from oxygen can include a syringe having aplunger slidably engaged with a barrel. The barrel and the plunger cancooperate to define a gas chamber. A case for providing substantialsterility can be configured to enclose the syringe. The syringe devicecan be configured to interface with an ozone generator.

In another exemplary embodiment, a method of producing an amount ofozone from oxygen for administering to a person can include providing avalvably-controlled fluid channel extending from a syringe through asterility case enclosing the syringe. A gas chamber of the syringe canbe filled with substantially pure oxygen gas via the valvably-controlledfluid channel. An electric current can be provided to one or moreconductive elements on the sterility case. The one or more conductiveelements can be connected to one or more electrodes. The one or moreelectrodes can be attached to the syringe. A corona discharge can beeffectuated from at least one electrode. An amount of ozone gas can beproduced from the oxygen gas.

In yet another exemplary embodiment, an ozone generation system caninclude a syringe device having a syringe enclosed by a sterility case.One or more electrodes can be attached to the syringe. One or moreconducting elements can be on the sterility case. The one or moreconducting elements can be directly or indirectly connected to the oneor more electrodes. An ozone generator with a high voltage supply can beconfigured to provide current to the one or more conducting elements.

BRIEF DESCRIPTION OF THE FIGURES

Advantages of embodiments of the present invention will be apparent fromthe following detailed description of the exemplary embodiments thereof,which description should be considered in conjunction with theaccompanying drawings in which:

FIG. 1 is a perspective view of an exemplary syringe device.

FIG. 2A is a top view of the exemplary syringe device of FIG. 1 thatfurther includes an exemplary sterility case.

FIG. 2B is a cross-sectional view along line A of FIG. 2A.

FIG. 2C is a cross-sectional view along line B of FIG. 2A.

FIG. 2D is an enlarged view of the portion circumscribed by line C ofFIG. 2C.

FIG. 3A is a side view of the exemplary syringe device of FIGS. 2A-2D inan initial state.

FIG. 3B is a side view of the exemplary syringe device of FIGS. 2A-2D ina filled state.

FIG. 3C is a side view of the exemplary syringe device of FIGS. 2A-2Dwith the exemplary sterility case detached.

FIG. 3D is a side view of the exemplary syringe device of FIGS. 2A-2Dwith the exemplary sterility case detached and the exemplary stopcockvalve in a closed state.

FIG. 3E is a side view of the exemplary syringe device of FIGS. 2A-2Dwith the exemplary sterility case detached and a portion starting at theexemplary filter detached.

FIG. 4A is a perspective view of an exemplary ozone conversion unit.

FIG. 4B is a perspective view of the exemplary ozone conversion unitwith the lid in an open position.

FIG. 4C is a perspective view of the exemplary ozone conversion unitcooperating with an exemplary syringe device.

FIG. 4D is a perspective view of the exemplary ozone conversion unithaving the exemplary syringe device received in a receptacle thereof.

DETAILED DESCRIPTION

Aspects of the invention are disclosed in the following description andrelated drawings directed to specific embodiments of the invention.Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention. Further, to facilitate an understanding of the descriptiondiscussion of several terms used herein follows.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. Likewise, the terms “embodiments ofthe invention”, “embodiment” or “invention” do not require that allembodiments of the invention include the discussed feature, advantage ormode of operation.

Referring to FIG. 1, a syringe device (without a sterility case portion)in accordance with at least one exemplary embodiment is shown. Syringedevice 100 (or any portion thereof) can be single-use and may bereprocessable. Alternatively, syringe device 100 (or any portionthereof) may be multi-use with sterilization, although such embodimentswould stray from current trends in healthcare. Syringe device 100 can befabricated, in whole or in part, by any conventional molding processesknown to one having ordinary skill in the art. Syringe device 100 canserve as a cell for producing an amount of ozone from oxygen when usedwith a suitable ozone conversion unit, as further described below.Optionally, syringe device 100 can be filled with substantially pure(e.g., medical grade) oxygen using a zeolite-based oxygen concentrator,as further described below. An ozone conversion unit and zeolite-basedoxygen concentrator can be provided for in one unit that can operativelyengaged syringe device 100. Syringe device 100, particularly, syringeportion 102 fitted (directly or indirectly) with a hypodermic needle canbe used to administer a therapeutic amount of ozone to a human or ananimal, as will be readily recognized by one having ordinary skill inthe art.

Syringe portion 102 of syringe device 100 can include barrel 104,plunger 106 and gas chamber 108. Gas chamber 108 can be defined andbounded through the cooperation of barrel 104 and plunger 106. In atleast one exemplary embodiment, syringe portion 102 can be sized to holdbetween 10 ml and 30 ml of fluid in gas chamber 108, including between10 ml and 30 ml of medical grade oxygen.

Barrel 104 can be made of any suitable material that allows for at leastsome UV transmission. This can allow for the passage of a UV beamthrough barrel 104 and a gas within gas chamber 108 for measuring theconcentration of ozone gas. Furthermore, barrel 104 can be constructedof any material that sufficiently balances the needs for ozoneresistance and UV resistance while still allowing for suitable UVtransmission for measuring the concentration of ozone. Flexibility inconstruction can be increased because syringe device 100 may only beexposed to ozone and UV light for a shortened/decreased period of time.

For example, barrel 104 (in which, syringe portion 102, as a whole, canbe constructed largely or wholly of the same) can be constructed ofpolyethylene, polytetrafluoroethylene (“PTFE”, TEFLON®), polyacrylate(acrylic polymers), polycarbonate, polystyrene, styrene copolymers,polypropylene and the like known to one having ordinary skill in theart. Barrel 104 can also be made of glass, as one more non-limitingexample. In at least one exemplary embodiment, barrel 104 can be made ofpolyethylene even though polyethylene may only allow about 10% UVtransmission. A UV transmission of about 10% can be enough to measureozone concentration within gas chamber 108 with suitable accuracy.

Plunger 106 can be slidably engaged with a first open end (i.e. top end)of barrel 104. The engagement of plunger 106 with barrel 104 can definethe bounds of gas chamber 108 within syringe portion 102. Throughsliding movements of plunger 106 within barrel 104, a fluid, including agaseous fluid (e.g., oxygen gas), can be drawn into and expelled fromgas chamber 108. Plunger 106 can include a plunger head 110 on one endof plunger shaft 112. On the other end of plunger shaft 112 can beplunger piston 114. Plunger piston 114 can form a gas-tight seal withbarrel 104. Plunger piston 114 may be made from or covered with rubberand the like known to one having ordinary skill in the art. Tip portion116 of syringe portion 102 can extend in fluid communication from asecond end of barrel 104.

Wire electrodes 118, 120 can extend inwardly within barrel 104. Wireelectrodes 118, 120 may be made to extend inwardly by providing wireelectrodes 118, 120 through barrel 104. Wire electrodes 118, 120 can beprovided through barrel 104 in a gas-tight manner. Wire electrodes 118,120 can be situated proximate the end of barrel 104 from which tipportion 116 can extend from. Placing wire electrodes 118, 120 towardsthe tip end (i.e. bottom end) of barrel 104 can assist or preventplunger 106 and wire electrodes 118, 120 from interacting in anon-beneficial manner, such as causing damage to or misplacement ofeither, or compromising the gas-tight sealing functionality of plungerpiston 114, leading to leakage.

Wire electrodes 118, 120 can be made of any suitable conductive materialknown to one having ordinary skill in the art. Wire electrodes 118, 120may be solid metal rods of a relatively simple construction, which maybe cost-effective. In addition, a dielectric material may cover aportion(s) of wire electrode 118 and/or 120 in at least one exemplaryembodiment.

Wire electrode 118 can extend inwardly towards the center of hollowbarrel 104 (i.e. the center of gas chamber 108). Wire electrode 118 maybreach barrel 104 once and may retain a gas-tight seal proximate thebreach. Wire electrode 118 can approach the center of gas chamber 108 incross-section. Wire electrode 118 can be the discharge electrode. Theend of wire electrode 118 situated within gas chamber 108 can form asharp point. Alternatively, the end of wire electrode 118 can be blunt.

Wire electrode 120 can extend inwardly and can transverse a crosssection of gas chamber 108. Wire electrode 120 can be straight (asshown) or can be curved. Wire electrode 120 may breach barrel 104 twiceand may retain gas-tight seals proximate the breaches. Wire electrode120 may transverse a cross section of gas chamber 108 off-center. Wireelectrode 118 and wire electrode 120 can exist in a substantiallyperpendicular relationship without contacting one another. In otherwords, wire electrode 118 and wire electrode 120 can extend from and/orenter barrel 104 at approximately a right angle. Wire electrodes 118,120 can also be disposed at substantially the same planar orientation incross-section. Wire electrode 120 can be the ground electrode forcompleting a circuit and may be used to sustain the current flow.

Electrical contact points 122, 124 can be disposed on the outside ofbarrel 104, as well as various other positions, as will be readilyrecognized to one having ordinary skill in the art. Electrical contactpoint 122 can be connected with wire electrode 118. Electrical contactpoint 122 may be an integral portion of wire electrode 118. Electricalcontact point 124 can be disposed on an end of wire electrode 120outside of syringe portion 102. Electrical contact point 124 can beconnected to wire electrode 120 and may be an integral portion thereof.

Electrical contact points 122, 124 can be indirectly connected(described below) to an ozone generation unit for effectuating a coronadischarge via wire electrodes 118, 120. Wire electrode 118 can be thedischarge electrode and wire electrode 120 can be the ground electrode.The corona discharge can be used to produce an amount of ozone gas fromoxygen gas within gas chamber 108. A user can predetermine the amount(e.g., concentration) of ozone desired through operation of a suitableozone conversion unit. For example, therapeutic levels for intradiscalinjection may be up to 6% ozone gas by volume and such concentrationsmay be selected by a user of a suitable ozone conversion unit.

In other embodiments, a pair of electrodes (and portions formingelectrical contact points) can be provided in a variety ofconfigurations. Moreover, either one or both of the pair of electrodescan be foil electrodes. Further, either one or both of the pair of theelectrodes can be positioned wholly outside of syringe portion 102.Pending U.S. patent application Ser. No. 11/976,362 (incorporated byreference below) discloses exemplary configurations for a pair ofelectrodes attached to syringe portion 102 and may be referred to forguidance.

In at least one exemplary embodiment, wire electrode 118 can be pairedwith a foil electrode. The foil electrode can be disposed on a portionof the inner wall of barrel 104. The foil electrode can be curved, forexample, consistent with the curvature of the inner wall of barrel 104.Alternatively, the foil electrode can be linear. The foil electrode canbe relatively thin as is a known characteristic of foil electrodes ingeneral. The foil electrode can be situated towards the tip end (bottomend) of barrel 104. Foil electrode 222 can be the ground electrode.

An electrical contact point for the foil electrode can be disposed onthe outside of barrel 104, as well as various other positions, as willbe readily recognized by one having ordinary skill in the art. Theelectrical contact point can be situated on a bottom portion of barrel104. The electrical contact point can be connected to the foil electrodeand may be an integral portion of foil electrode. The foil electrode canbe a one-piece insert having the electrical contact point. The foilelectrode can breach barrel 104 so as to have a face on a portion of thewall of barrel 104 and the electrical contact point on the outside ofbarrel 104. The foil electrode can breach barrel 104 in a gas-tightmanner.

In another exemplary embodiment, wire electrode 118 can be paired with afoil electrode attached on the outer wall of barrel 104 by any meansknown to one having ordinary skill in the art. The foil electrode can besituated proximate the bottom end (tip end) of barrel 104. Wireelectrode 118 can extend towards and approach a face of the foilelectrode with a portion of barrel 104 interposed there between. Thefoil electrode can be the ground electrode.

In yet another exemplary embodiment, a pair of wire electrodes can beconfigured in a substantially opposing relationship with one another.The wire electrodes can extend inwardly within barrel. The wireelectrodes may be made to extend inwardly by providing wire electrodesthrough barrel 104. The wire electrodes can be provided through barrel104 in a gas-tight manner.

The wire electrodes can extend inwardly towards the center of barrel104. The wire electrodes can approach the center of gas chamber incross-section. The wire electrodes can exist in a substantially opposingrelationship without contacting one another. The wire electrodes mayalso be disposed at substantially the same planar orientation incross-section. Each of the wire electrodes may breach barrel 104 onceand may retain a gas-tight seal proximate the breach.

Either of the wire electrodes can be the discharge electrode dependingon the connection to an ozone conversion unit. The other electrode canthen function as the ground electrode. The ends of wire electrodessituated within gas chamber 108 can form a sharp point. Alternatively,the ends of the wire electrodes can be blunt or a combination of onesharp end and one blunt end, respectively.

Each electrical contact point of each electrode can be disposed on theoutside of barrel 104, as well as various other positions, as will bereadily recognized to one having ordinary skill in the art. Theelectrical contact points can be respectively connected with the wireelectrodes and may be integral portions thereof.

In yet another exemplary embodiment, a pair of substantially opposingwire electrodes can be angled. The electrodes can be angled downwardsproximate the inner bottom portion of barrel 104, thus, not strictlyoccupying substantially the same planar orientation in cross-section. Asa result, the bottom portion of a barrel 104 can be shaped so as toaccommodate angled electrodes. For example, barrel 104 can be shaped tohave a conical bottom portion.

In a further exemplary embodiment, syringe portion 102 can include apair of foil electrodes. The foil electrodes can be elongated andgenerally resembling strips in configuration. The foil electrodes can bedisposed on the inner wall of barrel 104. Alternatively, in at least oneother exemplary embodiment, the foil electrodes can be disposed onportions of the outer wall of barrel 104.

The foil electrodes can be disposed on opposing portions of the innerwall of barrel 104. A face of each of the foil electrodes can be in anopposing relationship. Also, the foil electrodes may verticallytransverse a midportion of barrel 104.

The electrical contact surfaces/points can be disposed on the outside ofbarrel 104, as well as various other positions, as will be readilyrecognized by one having ordinary skill in the art. The electricalcontact surfaces can be situated on opposite side portions of barrel104. The electrical contact surfaces can be respectively connected tothe foil electrodes and may be integral portions thereof.

The foil electrodes can be one-piece inserts (e.g., molded inserts)having the electrical contact surfaces. The foil electrodes can breachbarrel 104 so as to have a face on a portion of the inner wall of barrel104 and the electrical contact surfaces on the outside of barrel 104.The foil electrodes can breach barrel 104 in a gas-tight manner. Eitherof the foil electrodes can be the discharge electrode depending on theconnection to an ozone conversion unit. The other electrode can thenfunction as the ground electrode.

Referring to FIG. 1 and FIGS. 2A-2D, valvably-controlled fluid channel126 can extend in fluid communication from tip portion 116 of syringeportion 102. Valvably-controlled fluid channel 126 can be providedthrough the cooperation of multiple valves and other fittings known toone having ordinary skill in the art. Alternatively, valvably-controlledfluid channel 126 can be provided by an integral structure (not shown).Valvably-controlled fluid channel 126 can be connected to syringeportion 102 in a variety of manners for providing valvably-controlledfluid communication with gas chamber 108, as will be readily recognizedby one having ordinary skill in the art.

As shown, valvably-controlled fluid channel 126 can be provided throughthe cooperation of first stopcock valve 128, first luer fitting 130,filter 132, second luer fitting/adaptor 134, sterility cap 136 withO-rings 138, third luer fitting/adaptor 140, fourth luer fitting 141 andsecond stopcock valve 142. All or less than all of the valves and otherfittings can be coupled in a removable manner. First stopcock valve 128can be fitted onto tip portion 116. First luer fitting 130 can couplefirst stopcock valve 128 to filter 132. Second luer fitting/adapter 134can couple sterility cap 136 to filter 132. Luer fittings 140, 141 canbe used to couple second stopcock valve 142. Alternatively, fourth luerfitting 141 or any other suitable fitting known to one having ordinaryskill in the art can be connected to an oxygen supply source forfilling, such as an oxygen tank or hospital supply line, as a couplenon-limiting examples. Luer fittings 130, 134, 140, 141 can be press-on,twist-on and the like. In further embodiments, other fittings and valvesknown to one of ordinary skill in the art can be used to providevalvably-controlled fluid channel 126.

Filter 132 can be any suitable filter for protecting gas chamber 108from contamination known to one having ordinary skill in the art. Forexample, suitable filters can include the QOSINA hydrophobic filter witha pore size of 5 μm and the MILLIPORE® Aervent-50 hydrophobic filterwith a pore size of 0.2 μm. Smaller pore size provides greaterfiltration but requires greater pressure to push gas into gas chamber108 of syringe portion 102. Both filters contain a PTFE membrane in apolypropylene casing. After ozone generation and prior to injection,sterility case 144 and filter 132 can be removed. By disengaging filter132, removed contaminants trapped by filter 132 are not forced back byreverse flow into the patient during injection.

By providing filter 132 within sterility case 144, a clinician does nothave the option of removing filter 132 without removing sterility case144, thus destroying the integrity of syringe device 102, if sterilitycase 144 is removed prior to ozone conversion. Thus, filter 132 can beused as an integrated part of syringe device 102 until sterility case144 is removed after ozone generation and prior to injection. This maybe beneficial because clinician will use filter 132, which is believedto be best practice. It may be convenient as filter 132 can already beprovided as an integrated part of syringe device 102. It may also urgethe industry to adopt filtration as a standard industry-wide practice,which may benefit the industry as a whole.

Sterility cap 136 can have a male portion and a grip portion. The maleportion can be designed to be inserted into an open end of sterilitycase 144 in snug engagement. The male portion may be cylindrical ifsterility case 144 is tubular, as one non-limiting example. Snugengagement of sterility cap 136 and sterility case 144 can form a seal,which may or may not be gas-tight. One or more O-rings 138 can bedisposed around the male portion of sterility cap 136 for facilitatingsnug engagement and can promote the formation of a seal betweensterility cap 138 and sterility case 144.

During snug engagement, the grip portion of sterility cap 136 can bordersterility case 144 and may project laterally in all directions. The gripportion of sterility cap 136 can be circular. The grip portion ofsterility cap 136 can provide a useful area for a user to manipulatesterility cap 136 to engage or disengage with sterility case 144. Thegrip portion may be contoured or textured for increased ease inmanipulation by a user's hands and fingers.

Sterility cap 136, as a whole, can have a channel defined through it,which can form a portion of valvably-controlled fluid channel 126. Whensterility cap 136 is engaged with sterility case 144,valvably-controlled fluid channel 126 can extend from tip portion 116through sterility cap 136 and, hence, through sterility case 144 becausesterility cap 136 can be viewed as a component thereof duringengagement.

Referring particularly to FIGS. 2A-2D, the syringe device of FIG. 1 isshown with a sterility case portion in accordance with at least oneexemplary embodiment. Syringe device 100 can include sterility case 144.Sterility case 144 can be rigid, flexible or any combination thereof. Inat least one exemplary embodiment, sterility case 144 can be made of arigid plastic material. Sterility case 144 can be tubular in shape, asone non-limiting example.

Sterility case 144 can prevent direct handling and other types ofphysical contact with syringe portion 102. By preventing direct handlingand other types of physical contact, sterility case 144 can decrease thelikelihood of contamination. Particularly, incidences of contaminationof gas chamber 108 can be reduced. Thus, the mere existence of sterilitycase 144 as a physical barrier may provide substantial sterility tosyringe portion 102. Sterility case 144 may or may not be gas-tight. Agas-tight seal may provide additional safeguards against contaminationof gas chamber 108. Overall, sterility case 144 can increase thelikelihood of a sterile dose of ozone being delivered to a patient.

As shown, sterility case 144 can be engaged with sterility cap 136 so asto house syringe portion 102, a portion of valvably-controlled fluidchannel 126, first stopcock valve 128, first luer fitting 130, filter132 and second luer fitting/adaptor 134 in a ship-in-a-bottleconfiguration. Sterility case 144 may or may not be sealed in agas-tight manner at its top end. For example, sterility case 144 can besealed by sterility end cap 146, which can be considered a component ofsterility case 144. Alternatively, sterility case 144 can have anintegral top portion. The components and portions housed withinsterility case 144 can remain substantially sterile after sterilizationof syringe device 100 because of the physical barrier provided bysterility case 144. Sterilization can be performed by gamma irradiationor any other method known to one having ordinary skill in the art. Aftersterilization, syringe device 100 can be packaged in Tyvek pouch, as onenon-limiting example. Gas chamber 108 can remain substantial sterilewhen fluid communication is obstructed through the operation of one ormore valves of valvably-controlled fluid channel 126 and/or by retainingplunger 106 in a depressed state. Filter 132 can also preventcontamination when fluid communication is or is not obstructed.

Sterility case 144 (or portions thereof) can be made of any suitablematerial and may allow for at least some UV transmission. UVtransmissibility can allow for the passage of a UV beam throughsterility case 144, barrel 104 (also having some UV transmissibility)and a gas within gas chamber 108 for measuring the concentration ofozone gas.

For example, sterility case 144 can be constructed of polyacrylatebecause of its UV transmission properties. In other embodiments,sterility case 144 can be constructed of polyethylene,polytetrafluoroethylene (“PTFE”, TEFLON®), polycarbonate, polystyrene,styrene copolymers, polypropylene and the like known to one havingordinary skill in the art. Sterility case 144 can also be made of glass,as one more non-limiting example.

First conducting element 148 and second conducting element 150 can beattached to or otherwise disposed on sterility case 144. Conductingelements 148, 150 can be of any conductive material, including variousmetals, known to one having ordinary skill in the art. As onenon-limiting example, conducting elements 148, 150 can be made ofberyllium copper alloy (“Be—Cu”). Conducting elements 148, 150 can eachbe a one-piece construction. Alternatively, conducting elements 148, 150can have more than one piece, as will be readily recognized by onehaving ordinary skill in the art. Conducting elements 148, 150, whetherone-piece or not, can have portions outside of and inside of, as well asa portion(s) in a breaching relationship with sterility case 144.Conducting elements 148, 150 may or may not breach sterility case 144 ina gas-tight manner. In exemplary embodiments, the holes required to passconducting elements 148, 150 can be covered with tape or sealed withepoxy, as couple non-limiting examples, if conducting elements 148, 150are not already passed in a gas-tight manner.

In single-use embodiments, a fuse (not shown) or interfering electricalcontacts can be coupled to one or more of conducting elements 148, 150.The fuse can be used as one means for identifying that syringe device100 has been previously used. Alternatively, singularly or inconjunction, one or both of conducting elements 148, 150 can “spring”out when the syringe device 100 is removed from a suitable ozoneconversion unit.

Conducting elements 148, 150 can be fashioned in a variety of shapes anddimensions. As shown, conducting elements 148, 150 can each have aring-shaped outer portion and a projecting portion for breachingsterility case 144. The projecting portion can be shaped (e.g., curvedand/or bent) so as to respectively reach and contact one of electricalcontact points 122, 124 when sterility case 144 is engaged withsterility cap 136.

When sterility case 144 is engaged with sterility cap 136, conductingelement 148 can contact electrical contact point 122 and conductingelement 150 can contact electrical contact point 124 for providingcurrent. Conducting elements 148, 150 can be electrical contact pointsin their own right for interfacing with electrical contact points of amedical ozone generator. A medical ozone generator can supply electricalcurrent through conducting elements 148, 150 and, in turn, throughelectrodes 118, 120 in order to effectuate corona discharge. The coronadischarge can be used to produce an amount of ozone gas from oxygen gaswithin gas chamber 108. A user can predetermine the amount (e.g.,concentration) of ozone desired through operation of a suitable ozoneconversion unit. For example, therapeutic levels for intradiscalinjection may be up to 6% and such concentrations may be selected by auser of a suitable ozone conversion unit.

Referring to FIGS. 3A-3E, syringe device 100 is shown in variousconfigurations for different states of use. Referring particularly toFIG. 3A, syringe device 100 is shown in a pre-use or initial state.Syringe device 100 can be provided as such, for example, from amanufacturer or vendor to a user. A user can be a clinician, such as adoctor or other medical personnel. Syringe device 100 can be providedfrom a manufacturer or vendor in a substantially sterile state. Forexample, syringe device 100 can be provided in sterile packaging, suchas a sterile pouch. Sterilization can be performed by any method knownto one having ordinary skill in the art, including gamma irradiation.Notably, plunger 106 can be provided in a depressed state. Secondstopcock valve 142 can be in a closed state to prevent contaminatingvalvably-controlled fluid channel 126.

Referring particularly to FIG. 3B, syringe portion 102 of syringe device100 can be filled with substantially pure oxygen gas (e.g., medicalgrade oxygen) via valvably-controlled fluid channel 126 and, thereafter,an amount of ozone gas can be produced from the oxygen gas in gaschamber 108. In at least one exemplary embodiment, syringe device 100can be connected to an oxygen concentrator for filling gas chamber 108with substantially pure oxygen gas. The oxygen concentrator can be partof the same unit as an ozone conversion unit. In another embodiment,syringe device 100 may be pre-filled with oxygen, sealed in a sterilitycase and then sterilized and packaged, in which case the sterility capwould not require a gas passage.

The oxygen concentrator can be consistent with any embodiment disclosedby U.S. patent application Ser. No. 11/976,362 (incorporated byreference below). Second stopcock valve 142 can be manipulated toprovision concentrated and substantially pure oxygen gas viavalvably-controlled fluid channel 126 to gas chamber 108 when syringedevice 100 is connected to such a filling apparatus. Filling can occurby pressurizing at least one zeolite chamber with ambient air. Thezeolite chamber can have at least one zeolite material that selectivelysorts nitrogen from oxygen. Stopcock valve 142 can be set to the openposition and syringe portion 102 (oxygen-ozone cell) can be filled withconcentrated oxygen gas from the at least one zeolite chamber viavalvably-controlled fluid channel 126. Filter 132 can decrease exposureof gas chamber 108 to contaminating agents.

Plunger 106 can be elevated during the filling process, whether beingfilled by an oxygen concentrator or other oxygen supply, due to pressurefrom the oxygen gas entering gas chamber 108. Gas chamber 108 can, thus,expand upon ingress of oxygen gas. Sterility end cap 146 (i.e. top endof sterility case 144) can act as a stopper for abutting plunger head110 to ensure that plunger piston 114 of plunger 106 is retained withinbarrel 104.

Once filled by an oxygen concentrator or other oxygen supply, syringedevice 100 can be operatively connected to an ozone generator, such asan exemplary ozone conversion unit disclosed in U.S. patent applicationSer. No. 11/527,414 (incorporated by reference below). If the oxygenconcentrator and ozone conversion unit are conjunctively housed, thenthere may be no need to disengaged syringe device 100. Alternatively, ifthe oxygen concentrator is a separate unit from the ozone conversionunit, then syringe device 100 can be disengaged from the oxygenconcentrator and operatively coupled to an ozone conversion unit.

Conducting elements 148, 150 can be interfaced with electrical contactpoints of an ozone generator. A medical ozone generator can supplyelectrical current through conducting elements 148, 150 and, in turn,through electrodes 118, 120 in order to effectuate corona discharge. Thecorona discharge can be used to produce an amount of ozone gas fromoxygen gas within gas chamber 108. A user can predetermine the amount(e.g., concentration) of ozone desired through operation of a suitableozone conversion unit. Alternatively, an ozone generator relying on UVlight for conversion can be used and conducting elements 148, 150, aswell as wire electrodes 118, 120 may not be needed in such embodiments.Therapeutic levels for intradiscal injection may be up to 6% and suchconcentrations may be selected by a user of a suitable ozone conversionunit.

Syringe device 100 can be disconnected from the ozone generator, whichmay be done shortly after ozone gas is produced. For example, theozone-oxygen gaseous mixture for intradiscal injection should bedelivered shortly after ozone gas is produced so that a significantamount of the ozone gas does not break down due to its short half-life.The ozone conversion unit can have the ability to hold the concentrationof ozone at a specific level by delivering voltage if the concentrationfalls. Once the syringe device 100 is disconnected from the machine, astopwatch function can be activated to encourage the clinician tocomplete the injection within a set time (e.g. three minutes). Secondstopcock valve 142 can be closed to decrease exposure to contaminatingagents as shown in FIG. 3C. Filter 132 can also function to decreaseexposure to contaminating agents whether or not stopcock valve 142 isplaced in a closed configuration.

Referring particularly to FIG. 3C-3E, after ozone is produce, sterilitycase 144 can be removed. The bottom open end of sterility case 144 canbe uncoupled from sterility cap 136. Nevertheless, gas in gas chamber108 can remain in a substantially sterile state, as would be expected.First stopcock valve 128 can be placed in the closed position and filter132 can be uncoupled from first luer fitting 130 and a delivery devicecan be coupled to luer fitting 130. Filter 132 can be removed prior toinjection so that the removed contaminants are not forced back into thepatient during injection. A clinician in the non-sterile field canremove sterility case 144 and the clinician can couple syringe device102 to a hypodermic needle. For example, a hypodermic needle can becoupled with luer fitting 130 for intradiscal injection of asubstantially sterile dose of ozone gas by a clinician (e.g., doctor,nurse, etc.).

The disclosures of unpublished U.S. patent application Ser. No.11/527,414 (Hooper), Ser. No. 11/727,978 (Hooper, et al.) and Ser. No.11/976,362 entitled “SYSTEM FOR DELIVERING OZONE”, “APPARATUS, METHODAND SYSTEM FOR DELIVERING OXYGEN-OZONE” and “SYRINGE, SYSTEM AND METHODFOR DELIVERING OXYGEN-OZONE”, respectively, are incorporated byreference herein in their entireties. As will be recognized by onehaving ordinary skill in the art, a syringe devices in accordance withat least one embodiment of the present disclosure can be suitablydesigned to functionally replace exemplary sterile vials (i.e.oxygen-ozone cells) of the '414 application for use with exemplary ozoneconversion units as otherwise disclosed (and further described hereinbelow), with or without ordinary modification, in the '414 application.Alternatively, conventional ozone generators, with or without ordinarymodification, can be used to convert a portion of oxygen gas to ozonegas within syringe devices in accordance with embodiments of the presentdisclosure.

There may not be a need to remove excess ozone from an ozone generatorbecause the amount of ozone needed (without substantial excess) can beproduced directly in an exemplary syringe device. An exemplary syringedevice adapted for direct cooperation with a medical ozone generator candecrease manufacturing costs by combining the functionality of an ozonecell (e.g., sterile vial) with a therapeutic delivery instrument (e.g.,a conventional syringe).

Moreover, syringe device embodiments can be suitably designed tofunctionally replace exemplary oxygen-ozone cells of the '978application. Such embodiments can be filled with concentrated oxygenusing exemplary apparatuses for concentrating oxygen from air asotherwise disclosed, with or without ordinary modification, in the '978application. Alternatively, oxygen can be supplied to exemplary syringedevices by any other means known to one having ordinary skill in theart. As a couple non-limiting examples, medical grade oxygen can besupplied from supply tanks or hospital supply lines.

An exemplary ozone conversion unit may include an ozone UV measurementassembly, a data input mechanism such as a dial to allow the user toselect a desired ozone concentration, and a data display to displayinput and output data such as desired concentrations and measurements.After a syringe device according to at least one exemplary embodiment isengaged to the ozone conversion unit, an ozone concentration may beselected and power applied to effect corona discharge and the resultantconversion of oxygen to the selected concentration of ozone. Anexemplary syringe device may then be disengaged, thus allowing fortherapeutic treatment. Embodiments may be employed in any of a varietyof situations including, for example, the therapeutic treatment ofhumans or animals by way of injection.

The ozone conversion unit may be used to convert an amount of oxygencontained in an exemplary syringe device to ozone by facilitating power.Ozone conversion unit may include a high voltage transformer. In anexemplary embodiment, the high voltage transformer may have a potentialdifference of about 3-25 kV. The high voltage transformer may beconnected to a power source and to another set of electrical contactpoints. In another exemplary embodiment, electrical contact points maybe arranged to reversibly interface with the electrical contact pointsof an exemplary syringe device.

The ozone conversion unit may further include an input device (e.g.,dial, keypad, touch screen, etc.), a UV measurement assembly and a datadisplay. The UV measurement assembly may include components relating tomeasurements using UV absorption techniques, whereby a beam is passedthrough the ozone and oxygen mixture to be received by a detector. Sucha beam may have a wavelength within a range on the UV spectrum known tothose skilled in the art to be absorbed by ozone such as ranges UV-A,UV-B, and UV-C. In an exemplary embodiment, a beam having wavelengths ofabout 253.7 nm, within the bounds of the UV-C range, may be used. Also,in an exemplary embodiment, a mercury vapor lamp may be used to measurethe concentration of ozone. An alternative exemplary embodiment mayemploy a UV light emitting diode or other instruments known to onehaving ordinary skill in UV absorption techniques. An exemplary detectormay be a photodiode or other photo detecting instruments known to thosehaving ordinary skill in the art. The dial may be used to regulate orinput a desired ozone concentration. An exemplary therapeuticallyeffective concentration of ozone is 6% or less by volume. An exemplarysyringe device may be constructed to be received by the ozone conversionunit in such a way that orients an exemplary syringe device forsuccessful UV measurement.

In an exemplary embodiment, the electrical contact points (e.g.,conducting elements 148, 150) may be situated to interface with theinterior of a receptacle formed in the ozone conversion unit that iscapable of receiving an exemplary syringe device. The UV measurementassembly may be arranged to orient a UV measurement beam axially throughand along the receptacle to be received by a UV detector. In analternative embodiment, the UV measurement assembly may be arranged toorient the UV measurement beam through the receptacle transversely. Afurther exemplary embodiment may include a door to be closed upon oraround an engaged exemplary syringe device, thereby reducing ambientlight from infiltrating the receptacle and interfering with UV detector.

The data display may be used to display measurement data collected by aUV measurement assembly, indicate power status, or convey other relevantinformation such as input data or to confirm engagement of an exemplarysyringe device within the ozone conversion unit and operating pressures.The data display may be used to display any information or data that maybe useful to one having ordinary skill in the art. The ozone conversionunit may be constructed to receive power, which can be made to passthrough the high voltage transformer, and both sets of electricalcontact points, thereby causing the corona discharge assembly to actupon the oxygen contained by an exemplary syringe device and effect theselected concentration of ozone.

Optionally, the exemplary ozone conversion unit may also be constructedto detect nitrogen oxides (NOx). If an exemplary syringe device iscontaminated with nitrogen, for example, due to ingress of air from suchcauses as a leak within the syringe device or improper functioning of afilling apparatus and system, then NOx will be produced by charging withthe ozone conversion unit. Absorption techniques can be used toindirectly detect nitrogen ingress into the syringe device prior tocharging. While nitrogen itself is optically transparent, NO_(x)molecules, which will be created from the ionization of nitrogen andoxygen, absorb light at various frequencies between 227 and 550 nm. ManyNO_(x) bands overlap with that of ozone making it difficult to isolatethese oxides. However, NO₂ has absorption bands (400-550 nm) that aredistinct from ozone (253.7 nm) making it well suited to detect nitrogeningress and formation of NO_(x)'s.

Also optionally, an exemplary ozone conversion unit or an exemplarysyringe device may be constructed to measure leaks within the syringedevice because at least one visual indicator or sensor for measuringchanges in pressure known to those having ordinary skill in the art maybe suitably placed for such a purpose. Moreover, the dielectric propertyof gases may provide another way to measure the amount of nitrogenpotentially within the syringe device. Oxygen and nitrogen havedifferent dialectic constants and may be detected based on thisdifference.

Referring to FIGS. 4A-4D, an exemplary ozone conversion unit is shown.Ozone conversion units consistent with the description above can beprovided in various designs, as will be readily recognized by one havingordinary skill in the art. FIGS. 4A-4D show, inter alia, a design for anexemplary zone conversion unit in accordance with at least one exemplaryembodiment.

Ozone conversion unit 400 can include housing 402 for housing componentsof ozone conversion unit 400. Housing 402 can frame data input anddisplay mechanism 404. In at least one embodiment, data input anddisplay mechanism 404 can be a touch screen. Data input and displaymechanism 404 can allow a user to input a variety of data and view avariety of inputted and outputted data. For example, data input anddisplay mechanism 404 can allow a user to select a desired ozoneconcentration. Moreover, data input and display mechanism 404 can beused to display measurement data collected by a UV measurement assembly,indicate power status, or convey other relevant information (e.g., inputdata, data confirming engagement of syringe device 100 within ozoneconversion unit 400, operating pressures, etc.).

Ozone conversion unit 400 can include receptacle 406. Receptacle 406 canbe accessed through the operation of lid 408. Within receptacle 406 canbe holder 410. Holder 410 can be pivotally mounted within receptacle406. Ozone conversion 400 can include guide 412 affixed to housing 402proximate holder 410 for guiding and confirming that holder 410 is in anupright position. Syringe device 100 can be fitted on holder 410 andholder 410 can be pivoted to provide syringe device 100 withinreceptacle 406 for generating an amount of ozone gas from oxygen gas.

The foregoing description and accompanying drawings illustrate theprinciples, preferred embodiments and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art.

Therefore, the above-described embodiments should be regarded asillustrative rather than restrictive. Accordingly, it should beappreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

What is claimed is:
 1. A syringe device, comprising: a syringe having aplunger slidably engaged with a barrel, the barrel and the plungercooperating to define a gas chamber; a case for providing substantialsterility, the case including an opening and configured to enclose thesyringe; a fluid channel penetrates through the opening of the case whenthe case operatively encloses the syringe, the fluid channel in fluidcommunication with the gas chamber; wherein the syringe and case areconfigured to interface with an ozone conversion unit, and the casemaintains sterility of the syringe while interfaced with the ozoneconversion unit to effectuate a corona discharge and produce an amountof ozone gas from an amount of oxygen gas within the gas chamber.
 2. Thesyringe device of claim 1, further comprising: a sterility cap having aportion that is configured to be inserted into the opening of the caseand allows for the fluid channel to extend through the sterility capwhen the case operatively encloses the syringe.
 3. The syringe device ofclaim 1, further comprising: a filter in fluid communication with thesyringe, the filter within the case when the case operatively enclosesthe syringe.
 4. The syringe device of claim 1, further comprising: afirst electrode and a second electrode attached to, or contacting, thesyringe; and two or more conducting elements on the case, the two ormore conducting elements including a first conducting element and asecond conducting element configured to directly or indirectly contactthe first electrode and the second electrode, respectively.
 5. Thesyringe device of claim 4, wherein the first electrode is one of a wireelectrode and a foil electrode and the second electrode is one of a wireelectrode and a foil electrode.
 6. The syringe device of claim 4,wherein at least one of the first electrode and the second electrode isin a breaching relationship with the barrel.
 7. The syringe device ofclaim 4, wherein the first conducting element and the second conductingelement breach the case, the first conducting element directlycontacting the first electrode and the second conducting elementdirectly contacting the second electrode.
 8. The syringe device of claim6 wherein at least one of the first conducting element and the secondconducting element have a projection in a breaching relationship withthe case, the projection for contacting one of the first electrode andthe second electrode.
 9. The syringe device of claim 1 wherein the caseincludes a removable sterility cap permitting the syringe to beextracted after a desired ozone concentration is produced.
 10. Thesyringe device of claim 1 wherein the case is rigid or flexible.
 11. Thesyringe device of claim 1 wherein the case is tubular.
 12. The syringedevice of claim 1 wherein the ozone conversion unit uses ultravioletlight to measure an amount of ozone.
 13. The syringe device of claim 1wherein the syringe device is configured to interface with an oxygenconcentrator, or a tank of substantially pure oxygen.
 14. The syringedevice of claim 1 wherein the case and the barrel allow for ultravioletlight transmission from the ozone generator to reach an inside andthrough the gas chamber.
 15. The syringe device of claim 1 wherein atleast one element springs out when the syringe device is removed toimpede reassembly.
 16. The syringe device of claim 1, wherein the fluidchannel is a valvably-controlled fluid channel extending from the barreland defined through at least one of: one or more stopclock valves; oneor more filters; one or more luer fittings; one or more O-rings; one ormore sterility caps; and any combination thereof.
 17. The syringe deviceof claim 4, wherein an electrical current is passed from the first andsecond conducting elements to the first and second electrodes.
 18. Asyringe device, comprising: a syringe having a plunger slidably engagedwith a barrel, the barrel and the plunger cooperating to define a gaschamber; a case for providing substantial sterility, the case includingan opening and configured to enclose the syringe; a fluid channelpenetrates through the opening of the case when the case operativelyencloses the syringe, the fluid channel in fluid communication with thegas chamber wherein the syringe and case are configured to interfacewith an ozone conversion unit, and the case maintains sterility of thesyringe while interfaced with the ozone conversion unit while the ozoneconversion unit uses ultraviolet light to convert an amount of oxygen toan amount of ozone.